What is a medical device and IVD certification checklist?
A certification checklist is a tool used to organize and systematize the steps necessary to prepare and carry out the conformity assessment process for medical devices and in vitro diagnostic devices (IVDs) in accordance with the MDR (2017/745) and IVDR (2017/746) regulations. Its purpose is to ensure complete documentation, procedural, and technical compliance before the product is submitted to a notified body or placed on the market.
In practice, the checklist combines legal requirements with industry best practices and facilitates the management of the certification process, minimizing the risk of errors, omissions, and delays in market access.
Why use a certification checklist?
Preparing for the certification of a medical device or IVD requires coordination across multiple areas, including risk assessment, technical documentation, clinical compliance, and implementation of a quality management system. In a context of evolving regulations, increasing demands from notified bodies, and shortened implementation timelines, a checklist serves as both a planning and control tool. It ensures that every required element has been addressed and documented.
Why must the checklist be tailored to the type of device?
Requirements vary depending on the device’s intended use, risk classification, and mode of operation. Medical implants, software as a medical device, PCR tests, or self-sampling kits follow different conformity assessment and documentation procedures. A generic checklist may overlook specific requirements. Therefore, it is essential to develop a personalized checklist — tailored to the specific device, its risk class, target population, and intended clinical scenarios.
Checklist scope step by step
The following points reflect the standard stages of certification preparation under MDR and IVDR, as well as the expectations of notified bodies and national regulatory authorities. Each step corresponds to a legal and technical requirement that must be fulfilled and documented before completing the certification process.
- Qualification and classification: Determine whether the product meets the definition of a medical device or IVD, and assign it to the appropriate risk class based on the rules in Annex VIII of MDR or IVDR.
- Conformity assessment and CE marking: Based on classification, select the relevant Annex (IX, X, or XI) and prepare for assessment by a notified body if required. Upon successful assessment, apply the CE mark according to Article 20 MDR/IVDR.
- Technical documentation: Develop complete documentation as per Annexes II and III of MDR/IVDR, including device description, risk analysis, clinical data, and manufacturing procedures.
- Clinical or performance evaluation: Prepare a Clinical Evaluation Report (CER) for medical devices or a Performance Evaluation Report (PER) for IVDs. These documents must demonstrate clinical or diagnostic compliance and be updated as part of the PMS system.
- Preclinical and usability testing: Conduct tests to verify the device’s safety and functionality, including biocompatibility, mechanical testing, stability, and usability studies (e.g., user error analysis, IFU readability).
- Quality management system: Implement a QMS based on ISO 13485, including procedures for control, traceability, supplier oversight, CAPA, and internal audits.
- Risk management: Follow ISO 14971 to identify hazards, assess and evaluate risks, implement controls, and analyze the effectiveness of mitigation measures.
- Post-market surveillance: Develop a PMS plan, and for higher-risk devices, implement PMCF (for MD) or PMPF (for IVD). Data collected under PMS should be used to update clinical evaluation, risk analysis, and technical documentation.
- Notified body selection: For higher-class devices, an agreement must be established with a notified body. Selection should consider its accreditation scope, experience, and procedural requirements.
- Device identification and registration: Implement a UDI system, prepare data for EUDAMED registration, and notify national registers in line with local authority requirements.
- Importer and distributor obligations: In accordance with Articles 13 and 14 MDR/IVDR, define the responsibilities of economic operators in the supply chain and ensure legal compliance (e.g., authority notification, documentation archiving, cooperation in corrective actions).
- Harmonised standards: Identify and apply relevant harmonised standards for the device type, and demonstrate their implementation in the technical file.
- Device notification and registration: Before placing the product on the market, register it with national authorities, e.g., URPL in Poland or relevant EU bodies.
- Free Sale Certificate: For exports to third countries, obtain a document confirming legal market placement and MDR/IVDR compliance — Free Sale Certificate (FSC).
How can Pure Clinical support certification checklist preparation?
Pure Clinical’s experts assist manufacturers in developing, reviewing, and implementing certification checklists tailored to the specific device and target market. Our services include gap analysis, compliance planning, technical and clinical documentation review, and preparation for collaboration with notified bodies. We also support QMS updates, PMS planning, risk management, and device registration in EUDAMED.
Thanks to our expertise in MDR and IVDR and close cooperation with regulatory bodies and notified bodies, our clients effectively complete certification processes while avoiding delays and formal errors.
Contact us to receive a customized checklist for your device and support at every stage of the conformity process.
FAQ
Can a certification checklist be used as audit evidence?
How often should the certification checklist be updated?
Does software as a medical device (SaMD) require a different checklist?